New Japan nods for GSK, Gilead, Actelion; Sagent CEO steps down; New Novo insulin meets trial goal;

@FiercePharma: Germany's cost watchdog decides Valeant's Provenge has added benefit after all. FierceVaccines story | Follow @FiercePharma

@EricPFierce: IPCA says FDA bans will have little sales impact. Didn't Wockhardt make that claim before its profits sank? Story | Follow @EricPFierce

@CarlyHFierce: Legal fallout from Valeant's failed Allergan siege? Experts debate. Story | Follow @CarlyHFierce

> The Swiss drugmaker Actelion won approval in Japan for its pulmonary arterial hypertension drug Opsumit, intended as a follow-up to its older drug Tracleer. Report

> Gilead Sciences ($GILD) won Japanese approval for its hepatitis C drug Sovaldi, as a treatment for patients with the genotype 2 form of the virus. Report

> GlaxoSmithKline ($GSK) nabbed Japanese approval for its new respiratory med Encruse Ellipta, to treat patients with chronic obstructive pulmonary disease. Report

> Sagent Pharmaceuticals ($SGNT) founder, Chairman and CEO Jeffrey Yordon stepped down from his executive positions, but will remain on the company's board; Sagent has launched a search for his replacement, and a committee will run the company in the interim. Release

> Novo Nordisk ($NVO) said a faster-acting version of its NovoRapid insulin met its goals in a late-stage trial. Report

> A rapid expansion in the U.S. 340B discount program, designed to aid "safety net" facilities, has led to calls for reform to make sure its benefits reach the neediest Americans. Report

Medical Device News

@FierceMedDev: ICYMI yesterday: Novartis rides med tech wave with new digital projects. Article | Follow @FierceMedDev

@EmilyWFierce: Cipla revs up for generic Sovaldi launch in India. FiercePharma story | Follow @EmilyWFierce

> J&J's DePuy inks deal with Radlink to market imaging tech with hip replacement devices. Article

> Zimmer: New outpatient program for Persona Knee patients is succeeding. Report

Biotech News

@FierceBiotech: $AMGN uncovers trove of gene knockouts in 'molecular national selfie.' Story | Follow @FierceBiotech

@JohnCFierce: ICYMI: Not giving up day job, but interviewing @Asthika from Bloomberg Intelligence on biotech market was fun. Watch | Follow @JohnCFierce

@DamianFierce: Sivextro v. Sovaldi. Vimizim v. Movantik. Belsomra lost?!? It's the Sweet 16 in @FiercePharma's #FierceMadness. Vote | Follow @DamianFierce

> Finance giants lobby for JOBS-style reforms to EU IPO laws. More

> FierceBiotech Radio on the biotech bubble and #FierceMadness. Listen

> Flagship banks $537M to back the next batch of biotechs. News

CRO News

> Recipharm pairs up with Adroit for chemistry services. Item

> Ergomed reaches into Asia on the hunt for co-development deals. Article

> BioClinica expands in NC after a string of buyouts. More

> Icon taps Carnegie Mellon to help patients better understand trials. Story

Vaccines News

> GlaxoSmithKline takes TB vaccine to Phase IIb. Item

> Emergent BioSolutions nabs government funds to test new-and-improved anthrax vaccine. News

> Chinese Ebola vaccine based on current strain looks safe in PhI. Story

> Germany's cost watchdog decides Valeant's Provenge has added benefit after all. Report

> GSK, U.K. 'hopeful' they can strike a Bexsero price deal soon. Article

Pharma Manufacturing News

> Indian state to train employees to think like FDA inspectors. Item

> San Francisco requires drugmakers to fund disposal of unused meds. News

> Tolmar adds warehouse to support new manufacturing facility. Article

> Deal done, Sun Pharma must now fix Ranbaxy's deep problems. Story

> FDA bans 2 more IPCA plants. More

Pharma Asia News

> U.S.-based Chinese researcher pleads guilty in United Imaging Healthcare bribery case. Report

> Pleasantries aside, U.S. FDA keeps sharp eye on India pharma manufacturing. Article

> Glenmark on yo-yo string sales journey with diabetes generics in U.S. More

> Actelion's PAH drug Opsumit gets Japan marketing nod, GSK's Encruse approved. Story

> Japan's MHLW approves Gilead's Sovaldi for genotype 2 chronic hep C. Article

And Finally... The state of Texas obtained a new supply of an execution drug from a compounding pharmacy as drugmakers seek to keep their sedative products out of prisons in death-penalty states. Report

Suggested Articles

Amid a tough fight in the blood thinner market, J&J and Bayer's Xarelto scored a trial win in treating PAD patients after a recent leg artery surgery.

Experts say it's worth exploring whether a Roche stroke drug could help certain COVID-19 patients.

Bluebird said it doesn't expect to complete a U.S. application for the gene therapy until mid-2021 amid COVID-19 and a lack of agreement with the FDA.